Bruce Klopfenstein

Global CQV and Turnover Leader with 30+ years delivering GMP-compliant facilities, equipment, utilities, and computerized systems across pharma, biotech, ATMP, and semiconductors. My experience spans full lifecycle commissioning, qualification, validation, construction turnover, and regulatory readiness for projects ranging from $50M expansions to multi-billion-dollar greenfield sites. Specializing in ISPE C&Q Baseline Guide v2, ASTM E2500, CSV/CSA - 21 CFR 11, and risk-based qualification, with expertise in building teams, simplifying workflows, accelerating startup, and ensuring regulatory compliance. I have led CQV and turnover groups of up to 30 engineers, delivered facilities across Europe and the U.S., and managed project scopes involving HVAC, process equipment, clean/black utilities, automation, and data systems. My background includes BSME, MBA, PMP, Kneat Power User certification, and work in engineering, automation and controls, operations, and project management. Having lived and worked in France, Switzerland, Sweden, Taiwan, the U.S., and Scandinavia, I bring a unique global perspective supported by dual U.S.–French citizenship and fluency in English/French.